(143 days)
Indicated for use in photocoagulation of both anterior and posterior segments, including:
- Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
- Proliferative and nonproliferative diabetic retinopathy
- Choroidal neovascularization
- Branch retinal vein occlusion
- The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
- Retinopathy of prematurity
- Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma
Intended for use in ophthalmic surgical procedures.
The Photocoagulator Opto Mitra Yellow Laser is equipment capable of making human retinal photocoagulation by laser application at 586nm (yellow laser). The coagulation (clotting) of tissue using a laser which produces light in the visible yellow (586nm) wavelength that is selectively absorbed by hemoglobin, the pigment in red blood cells, in order to seal off bleeding blood vessels. Photocoagulation has diverse uses such as, for example, in cancer treatment to destroy blood vessels entering a tumor and depriving it from nutrients; in the treatment of a detached retina, to destroy abnormal blood vessels in the retina, to treat tumors in the eye, etc.
The equipment consists of three encoders which enable the physician to adjust the pulse duration, the laser power and the interval between successive pulses. All information is displayed on a color display 240x324 pixels TFT technology. On this display there is a touch-screen film responsible for the navigation software and by setting preferences, such as loudness, intensity laser sighting and display brightness.
Physicians have the option of applying single pulses or pulse trains previously adjusted. Power levels ranging from 50mW up to 2000MW, with resolution of 10mW. The duration can be set between 100ms and 3000 ms with a resolution of 10ms. The interval between pulses can be set between 100ms and 3000ms with 10ms resolution or can be set to single pulse (in this case, the range is set to zero).
The Opto Mitra Yellow Laser beam has a wavelength of 586nm, which is in the visible spectrum and is a yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery.
The Opto Mitra Yellow Laser is a solid state, Optical Pumped Semiconductor surgical laser.
It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 586nm.
Compatible delivery devices include: slit lamp adapters/, laser indirect ophthalmoscopes (LIO) and endoprobe. All these accessories are specific for Opto Mitra Yellow Laser.
The provided text describes a medical device, the Opto Mitra Yellow Laser, and its general performance standards and equivalency to predicate devices. However, it does not include the specific details required to answer the questions about acceptance criteria, a specific study proving it meets those criteria, sample sizes, ground truth establishment, or clinical performance metrics (like sensitivity, specificity, or MRMC study results).
The document is a 510(k) summary for the Opto Mitra Yellow Laser, which primarily focuses on demonstrating substantial equivalence to previously cleared devices. This type of submission typically relies on non-clinical performance data (bench testing) and comparison to predicate devices, rather than new clinical trials with detailed statistical analysis of human reader performance or ground truth establishment.
Here's why the requested information cannot be fully provided based on the input:
- Acceptance Criteria & Reported Performance: The document provides technical specifications (e.g., wavelength, power, pulse duration, interval between pulses) as part of the device description, but these are not explicitly presented as "acceptance criteria" met by a study. Instead, they are characteristics of the device. There's no table comparing a predefined acceptance criterion to a measured performance value. The closest is the "Laser specification" on page 3, which lists the intended operating ranges and maximum errors, but these are design specifications, not study results against acceptance criteria.
- Sample Size (Test Set), Data Provenance: Not mentioned.
- Number of Experts, Qualifications, Adjudication Method: Not mentioned, as no human-in-the-loop clinical study is described.
- MRMC Comparative Effectiveness Study: The document states that "Non-clinical performance data and conclusions from non-clinical tests Laboratory testing was conducted to validate and verify that the proposed device, Opto Mitra Yellow Laser meets all design specifications and is substantially equivalent to the predicate device." This indicates a reliance on bench testing and comparison to predicates, not a clinical trial with human readers. Therefore, no effect size of human improvement with AI is provided.
- Standalone Performance: While the device itself is a standalone laser system, the concept of "standalone performance" in the context of diagnostic AI (sensitivity, specificity) does not apply here. The document states that "Laboratory testing was conducted to validate and verify that the proposed device, Opto Mitra Yellow Laser meets all design specifications and is substantially equivalent to the predicate device."
- Type of Ground Truth: Not mentioned, as no clinical study with ground truth determination is described.
- Sample Size (Training Set): Not applicable, as this is not an AI/ML diagnostic device that requires a training set in that sense.
- Ground Truth for Training Set: Not applicable.
Based on the provided text, here is the information that can be extracted, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit clinical acceptance criteria (e.g., a specific success rate for photocoagulation) and corresponding clinical performance results from a study are not provided in the 510(k) summary, this table focuses on the technical specifications and performance characteristics mentioned for the device. The "Acceptance Criteria" here are interpreted as the stated design specifications or maximum allowable errors for the device's operational parameters.
| Acceptance Criteria (Stated Design Specification) | Reported Device Performance (Implied from Design) |
|---|---|
| Laser: | |
| Wavelength: 586nm (± 3nm) | 586nm (± 3nm) |
| Max Output Power: 2000mW | Max 2000mW |
| Power Resolution: 10mW | 10mW |
| Max Error (Power): ± 20% | Implied to meet ± 20% |
| Aiming Laser: | |
| Wavelength: 635nm (± 20nm) | 635nm (± 20nm) |
| Max Output: 0.7mW (± 0.2mW) | 0.7mW (± 0.2mW) |
| Pulse Duration: | |
| Range: 10ms to 1000ms | 10ms to 1000ms |
| Max Error: 10% | Implied to meet 10% |
| Interval between Pulses: | |
| Range: 50ms to 3000ms | 50ms to 3000ms |
| Max Error: 10% | Implied to meet 10% |
| Single pulse option | Available |
| FastPulse Configuration: | |
| Period: 1800 us to 2200 us (± 100 us) | Meets 1800 us to 2200 us (± 100 us) |
| Duty-Cycle: 5% to 15% (± 1%) | Meets 5% to 15% (± 1%) |
| Safety and Standards: | |
| Compliance with IEC 60825-1:2007 | Compliant |
| Compliance with IEC 60601-2-22:1995 | Compliant |
| Compliance with IEC 60601-1:1988+A1:1991+A2:1995 | Compliant |
| Compliance with IEC 60601-1-2:2001 | Compliant |
| Compliance with IEC 60601-1-4:2000 | Compliant |
| Compliance with European Medical Directive 93/42/EEC & 2007/47/EEC | Compliant |
| Compliance with US Federal Standards 21 CFR 1002.10 Req. (CFR 1040.10, 1040.11), 1010.2, 1010.3 | Compliant |
| Compliance with Part 820 - Quality System Req. | Compliant |
| ISO 9001 and 13485 System Certification | Certified |
| Compliance with IEC 62304:2006 | Compliant |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not mentioned. The document primarily refers to "non-clinical performance data and conclusions from non-clinical tests (Laboratory testing)" to validate design specifications. No clinical test set involving human subjects is described.
- Data Provenance: Not applicable for a clinical test set, as none is described. Laboratory testing would be conducted internally by the manufacturer, Opto Eletrônica S/A (Brazil).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set requiring expert ground truth establishment is described.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is a medical laser system, not an AI diagnostic tool.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself, the Opto Mitra Yellow Laser, is a standalone medical device. The "standalone performance" mentioned in the document refers to its technical specifications and compliance with safety standards as verified through laboratory testing.
- The document states: "Laboratory testing was conducted to validate and verify that the proposed device, Opto Mitra Yellow Laser meets all design specifications and is substantially equivalent to the predicate device." This refers to non-clinical, bench-top testing of the device's technical performance parameters (e.g., power output, wavelength accuracy, pulse duration).
7. The type of ground truth used:
- Ground truth in the traditional sense (e.g., pathology, clinical outcome, expert consensus for diagnosis) is not explicitly discussed as part of a performance study for this device type. For a laser device, "ground truth" during development and testing likely refers to engineering specifications and performance benchmarks (e.g., a power meter as "ground truth" for laser output power, a spectrometer for "ground truth" on wavelength).
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML diagnostic device with a "training set" in that context.
9. How the ground truth for the training set was established:
- Not applicable.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.